510(k) · Cleared
ClearedMICRORAPTOR Knotless Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith and Nephew, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Sep 28, 2018 as substantially equivalent to K180361 (Smith and Nephew, Inc., 2018) and 1 other predicate after an 88-day review. Its family tree reaches back 8 generations to 1996. 3 later devices descend from it.
- Decided
- Sep 28, 2018
- Review
- 88 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K961555 (1996). 16 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 7 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 6 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 5 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 4 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- 3 generations backK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · Recalled
- 2 generations backK101459 Osteoraptor II Suture Anchor or to BE Determined Model: 72202764…Smith & Nephew, Inc. · 2011
- 1 generation backK180361 MICRORAPTOR REGENESORB Suture AnchorSmith and Nephew, Inc. · 2018
- This deviceK181746 MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK251809 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK260561 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK252314 Arthrex SutureTak Suture AnchorArthrex, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −7 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −6 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −5 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −4 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| −3 | K082215 | Osteoraptor Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2008 | 9 |
| −2 | K101459 | Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765… | Smith & Nephew, Inc. | 2011 | — |
| −1 | K180361 | MICRORAPTOR REGENESORB Suture Anchor | Smith and Nephew, Inc. | 2018 | — |
| 0 (this device) | K181746 | MICRORAPTOR Knotless Suture Anchor | Smith and Nephew, Inc. | 2018 | — |
| +1 | K251809 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2025 | — |
| +2 | K260561 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2026 | — |
| +1 | K252314 | Arthrex SutureTak Suture Anchor | Arthrex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MAI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180361 | MICRORAPTOR REGENESORB Suture AnchorSummary page 4…Submission Clearance Date Number MICRORAPTOR REGENESORB Suture K180361 May 30, 2018 Anchor BIORAPTOR 2.3 PK Suture Anchor K071586 Aug… | 2018 |
| * | K071586 | Bioraptor 2.3 PK Suture AnchorSummary page 4…MICRORAPTOR REGENESORB Suture K180361 May 30, 2018 Anchor BIORAPTOR 2.3 PK Suture Anchor K071586 August 17, 2007 Device Description The MICRORAPTOR Knotless Suture Anchor consists of an anchor on… | 2007 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 9 of the 16 ancestors have a recall of any class.
- Of its descendants, K251809 (Arthrex, Inc., 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Smith & Nephew MICRORAPTOR Knotless Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications:
Hip
• Acetabular labrum repair/reconstruction
Shoulder
• Capsular stabilization
– Bankart repair
– Anterior shoulder instability
– SLAP lesion repairs
– Capsular shift or capsulolabral reconstructions
• Biceps tenodesis
• Rotator cuff tear repairs
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181746 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181746: MICRORAPTOR Knotless Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181746
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026